Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation
This study is ongoing, but not recruiting participants.
Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01491178
First received: December 12, 2011
Last updated: August 1, 2016
Last verified: August 2016
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Purpose
To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation |
Drug: Prazaxa |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Patients With Nonvalvular Atrial Fibrillation |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- Incidences of adverse drug reactions [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of systemic embolism [ Time Frame: up to 104 weeks ] [ Designated as safety issue: Yes ]
- Incidence of stroke [ Time Frame: up to 104 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 6100 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Patients with NVAF |
Drug: Prazaxa
Dabigatran etexilate
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
5000
Criteria
Inclusion criteria:
- Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included.
Exclusion criteria:
- None
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491178
Show 1164 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491178
Show 1164 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01491178 History of Changes |
| Other Study ID Numbers: | 1160.130 |
| Study First Received: | December 12, 2011 |
| Last Updated: | August 1, 2016 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on September 23, 2016